Estradiol
- Product NDC
- 47781-104
- 11-digit product format
- 477810104
- Labeler code
- 47781
- Product ID
- 47781-104_0b1e69bc-c423-7849-4acc-b62466b70103
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- CREAM
- Route
- VAGINAL
- Labeler
- Alvogen Inc.
- Application
- ANDA209767
- Marketing category
- ANDA
- Marketing start
- 2018-03-05
- Marketing end
- 2027-06-01
- Substance
- ESTRADIOL HEMIHYDRATE
- Active strength
- .1 mg/g
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Estradiol
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTRADIOL HEMIHYDRATE | .1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CXY7B3Q98Z |
| Rxcui | 310169 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47781-104-44 | Estradiol | 42.5 g in 1 TUBE, WITH APPLICATOR | CREAM | 42.5 | | 10 |
| 47781-104-44 | Estradiol | 1 in 1 CARTON | CREAM | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47781-104 | ESTRADIOL CREAM [ALVOGEN INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241019_0178a92c-62b1-d5cf-cf54-2c85af88a74a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47781-104-44 | 47781010444 | 1 TUBE, WITH APPLICATOR in 1 CARTON (47781-104-44) / 42.5 g in 1 TUBE, WITH APPLICATOR | 2018-06-25 | 2027-06-01 | No | No | Current |